Definition: A Light Based Non-laser Device That Provides Thermal Effect Including Broad Spectrum Source Devices Such As Intense Pulse Light (ipl). Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic.
| Device Type ID | 5816 |
| Device Name | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Physical State | The Device Comes In A Wide Verity Of Shapes And Sizes. It Could Be Hand Held And With Weight Less Than One Pound Or It Could Be Heavy With Weight More Than Fifty Pounds. It Generally Has A Base Station With Attachments Such As Different Hand Piece(s) |
| Technical Method | This Is A Light Based Non-Laser Device That Provides Thermal Effect Including Broad Spectrum Source Devices Such As Intense Pulse Light (IPL) That Uses Light Energy To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue. The Classificatio |
| Target Area | The Device Generally Targets Skin (including Dermis, Epidermis) And Underlying Soft Tissue Or Soft Tissue In General. |
| Regulation Description | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4810 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ONF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 5816 |
| Device | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Product Code | ONF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| CFR Regulation Number | 878.4810 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALMA INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALMA LASERS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELLIPSE A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FORMATK SYSTEMS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLOBAL MEDICAL TECHNOLOGY S.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHASER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VENUS CONCEPT LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
YBK INVESTMENT INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Use Of Device Problem | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Accessory Incompatible | 1 |
| Total Device Problems | 8 |